O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100

Electrosurgical, Cutting & Coagulation & Accessories

MEDTREX, INC.

The following data is part of a premarket notification filed by Medtrex, Inc. with the FDA for O.r.pro 300 Electrosurgical Generator Model 40001-100.

Pre-market Notification Details

Device IDK981724
510k NumberK981724
Device Name:O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant MEDTREX, INC. 9712 S. ALTAMONT DR. Sandy,  UT  84092
ContactWilliam E Mckay
CorrespondentWilliam E Mckay
MEDTREX, INC. 9712 S. ALTAMONT DR. Sandy,  UT  84092
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-15
Decision Date1998-06-22
Summary:summary

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